Kornimate/medical-research-clean huggingface dataset:
effects of repeated mesenchymal stem cells (msc) in patients with progressive multiple sclerosis

Conditions: Multiple Sclerosis

Summary: an open prospective study with multiple (every 6-12 months) intrathecal or intravenous injections of autologous msc in patients with progressive forms of ms (secondary progressive, primary progressive or relapsing-progressive), who failed to respond to first and second lines of immunomodulatory treatments and deteriorated (at least 0.5 degree in the edss scale) during the year preceding their inclusion to our study or had at least one major relapse without sufficient recovery.

an open prospective study with multiple intrathecal or intravenous injections of autologous msc in 24 patients with progressive forms of ms (secondary progressive, primary progressive or relapsing-progressive), who failed to respond to first and second lines of immunomodulatory treatments and deteriorated (at least 0.5 degree in the edss scale) during the year preceding their inclusion to our study or had at least one major relapse without sufficient recovery. patients will be treated with 1x10 million msc per kg of body weight, intrathecally and intravenously and subsequently with up to 8 courses of it- or iv-injections of msc (at the same dose), at intervals of 6-12 months. the duration of the trial is 4 years. patients will be followed up every 3 months for the whole duration of the trial, for safety assessment and changes in the disability scores (edss). immunological analysis will be performed at 4 time points (day 1, month 1, month 3 and month 6) following the first msc-treatment and will include a fluorescent cell sorter (facs) analysis to evaluate the proportions of the lymphocytes expressing markers of immune activation or of regulatory cell phenotype.

Eligibility criteria:
inclusion criteria: 1. consenting patients fulfilling the poser's criteria for definite ms 2. age 18-70 3. male and female 4. edss rate 5.5-7.5 (moderate to high disability) 5. failure to two lines of the currently available registered immunomodulatory treatments for ms. the lack of response to these treatments was determined by either an increase in edss or the appearance of at least two relapses of ms during the year prior to inclusion. exclusion criteria: 1. patients who were treated with cytotoxic medications during the last three months prior to the infusion. 2. patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results. 3. patients with active infections. 4. patients with cognitive decline or inability to understand and sign the informed consent.

Keywords: multiple sclerosis mesenchymal stem cells
effect of egb 761® on patients with mild to moderate alzheimer's disease

Conditions: Alzheimer Disease

Summary: the aim of this study is to measure the effect of egb 761® versus placebo on the ratio of the isoform of the protein precursor of beta amyloid platelets, in patients with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * female or male of 50 to 85 years old with a care giver * mini mental status (mms) test between 16 to 26 inclusive * clinical dementia rating (cdr) test inferior or equal to 1 * national institute of neurological and communicative disorders and stroke / alzheimer's disease and related disorders association (nincds/adrda) test positive for an alzheimer's disease * diagnostic and statistical manual of mental disorders, 4th edition (dsm iv) test positive for dementia exclusion criteria: * patient already treated by medicines which could interfere with the study * low level of vitamin b12 and folate which are considered as clinically relevant * clinically relevant pathologies (eg: pulmonary illness, cardiovascular illness; evolutive cancer, neurological illness, blood illness....)
study of intensive care unit (icu)-acquired weakness (handgrip strength study)

Conditions: Peripheral Muscle Strength

Summary: to better understand icu-acquired weakness in patients requiring mechanical ventilation in the intensive care unit.

we have generated the hypothesis that handgrip strength can be used to develop our understanding of the effects of critical illness on peripheral muscle strength. to begin to develop this hypothesis, a better understanding of the determinants of handgrip strength needs to be developed. as a result we propose to perform a prospective observational study examining the clinical factors that are associated with handgrip strength. several clinical factors are known to be associated with increased risk of developing icuap while hospitalized: multiple organ failure, severe sepsis, female gender and treatments like steroids. as many of these risk factors are not modifiable, the opportunity to intervene is unclear. however, by attempting to better describe the spectrum of strength deficits experienced by critically ill patients we may better be able to dissect and prevent icuap.

Eligibility criteria:
inclusion criteria: * • adult patients admitted to the medical icu * age ≥ 18 years of age at icu admit. * requiring mechanical ventilation for at least 24 hours exclusion criteria: * • moribund or in the process of withdrawal of life support * patient, family or physicians not in favor of continued support until awakening. * profound neurologic injury associated with little or no chance of awakening. * active consideration of a diagnosis of brain death by treating physicians. * known history of chronic neurological disease resulting in muscle weakness in more than two limbs. * inability to perform handgrip dynamometry prior to acute illness. * subject is a non-english speaker * subject or surrogate unable to provide informed consent. * icu stay of greater than 24 hours within the last thirty days or at any point during the current hospitalization * greater than seven days of hospital care prior to hospital admission. * greater than five days since inclusion criteria met.

Keywords: icu acquired paresis
a 14-day study of racivir when used in combination in hiv-infected males

Conditions: HIV Infections

Summary: the purpose of this study is to evaluate racivir. the safety, most effective dosage, and how the body reacts to racivir will be studied.

the study is a 14-day study with a 21-day follow-up period. during the 14-days of active study period, participants will receive racivir once daily in combination with efavirenz and stavudine. following the administration of the first and last dose of study medication, patients will remain in the clinic overnight. during the study there will be medical and medication histories taken, physical examinations, vital sign measurements, ekgs, and routine clinical laboratory tests.

Eligibility criteria:
inclusion criteria subjects may be eligible to participate if they: * are males with hiv infection with a positive hiv antibody test * have an hiv-rna copy number of ≥ 5000 copies/ml (roche assay) * have cd4+ cell counts ≥ 50 cells/ml * are 18-45 years of age, inclusive * have a body mass index (bmi) ≥ 18 kg/m2 * are antiretroviral nucleoside reverse transcriptase inhibitor-naive * have read and understand the informed consent,and is able and willing to comply with study procedures exclusion criteria subjects may not participate if they: * have clinically significant ecg abnormalities * have clinically significant abnormalities in any safety laboratory parameters * have an alt value ≥ 3xunl * have previously participated in this trial * have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug * have a history of chronic alcohol or drug abuse within the last 6 months * have a positive urine drug screening * have a positive alcohol breath test * have any medical or psychiatric condition, which in the opinion of the investigator would jeopardize or compromise the subject's ability to participate in this trial * have a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol

Keywords: treatment experienced hiv phase i combination therapy
irinotecan with docetaxel in treating patients with recurrent or metastatic non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining irinotecan and docetaxel in treating patients who have recurrent or metastatic non-small cell lung cancer.

objectives: i. evaluate the response rate of previously treated patients with recurrent non-small cell lung cancer after treatment with irinotecan and docetaxel. ii. determine the toxicity of this regimen in these patients. iii. determine the overall survival in this patient population. outline: patients receive irinotecan iv over 90 minutes immediately followed by docetaxel iv over 60 minutes on day 1. treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 5 years or until death.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed non-small cell lung cancer (nsclc) reconfirmation of nsclc required only if complete response for greater than 1 year measurable or evaluable disease tumor shrinkage or stability for at least 4 weeks on initial chemotherapy cns metastases allowed, if symptoms controlled for greater than 8 weeks after surgery or radiotherapy patient characteristics: age: 18 and over performance status: 0-1 life expectancy: at least 12 weeks hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin normal ast no greater than 2 times upper limit of normal (uln) renal: creatinine no greater than 2.5 times uln cardiovascular: no new york heart association class iii or iv heart disease other: no active infection at least 5 years since any other prior malignancy except curatively treated basal or squamous cell skin cancer, carcinoma in situ, or other cancers no grade 2 or worse peripheral neuropathy no uncontrolled diabetes mellitus no other serious underlying disease not pregnant or nursing fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics no greater than 1 prior nsclc chemotherapy regimen, excluding low dose cisplatin as a radiosensitizer no prior irinotecan or docetaxel at least 4 weeks since prior chemotherapy endocrine therapy: not specified radiotherapy: see disease characteristics at least 4 weeks since prior radiotherapy no prior radiotherapy to greater than 25% of bone marrow surgery: see disease characteristics other: no concurrent phenytoin, phenobarbital, or other anticonvulsants

Keywords: recurrent non-small cell lung cancer stage iv non-small cell lung cancer
use of banana leaf dressing on donor site wounds

Conditions: Burn

Summary: prospective randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of banana leaf dressing versus hydrocolloid dressing.

prospective randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of banana leaf dressing versus hydrocolloid dressing. adult patients with no uncontrolled medical condition admitted at philippine general hospital burn center requiring split thickness skin graft for their burn. this is to compare the efficacy and safety of banana leaf dressing with hydrocolloid dressing among patients undergoing split thickness skin graft for their burn.

Eligibility criteria:
inclusion criteria: * patient undergoing harvesting of skin graft one or both thigh * surgery under general anesthesia * given informed consent and has accomplished a written inform consent exclusion criteria: * patient with uncontrolled medical condition such as diabetes or hypertension * pregnant females * patients in whom legs or back was used as donor site * surgery under regional anesthesia * refused inclusion into the study * patients who had previous skin harvesting on the area of the study
study of zggs18 in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: a clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of zggs18 in patients with advanced solid tumors


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed the available standard treatments or no standard treatment or intolerance to standard treatment; * eastern cooperative oncology group (ecog) performance status of 0 or 1; * life expectancy ≥ 3 months; * must have at least 1 measurable lesion per response evaluation criteria in solid tumors 1.1(recist1.1). for lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions. exclusion criteria: * the investigator considers that any subjects are not suitable to participate in the trial.
digital analysis of mesiodistal tooth width

Conditions: Measurement of Crown Width of Permanent Teeth

Summary: the goal of this cross-sectional study is to determine the digital permanent crown tooth width

using digital intra oral scanning to measure the permanent tooth mesiodistal dimension

Eligibility criteria:
inclusion criteria: * children range age 12-15 years old. * complete set of permanent dentitions with intact marginal ridges. * fully erupted teeth to the occlusal plane. * normal occlusion without crowding, rotation, spacing. * healthy children with no systemic diseases. exclusion criteria: * buildups, crowns, onlays, class ii restorations that affect a tooth mesiodistal * diameter. * congenital defects or deformed teeth or congenital missing teeth. * obvious interproximal or occlusal wear of teeth. * anterior teeth fractures.

Keywords: tooth size, mesiodistal width, egyptian children.
improving hiv diagnosis, linkage to care, and prevention services with hiv point-of-care nucleic acid tests

Conditions: HIV Infections

Summary: this project will develop, implement, and evaluate models for use of point-of-care nucleic acid testing (poc nat) among hiv-negative persons seeking hiv testing, pep, and prep and hiv-positive persons in community and clinical settings. study aims #1 and #2 will evaluate the sensitivity and specificity of a qualitative poc nat in persons not known to be hiv-positive and will determine the impact of its use on prep uptake and persistence among persons testing hiv-negative and on time to hiv continuum of care outcomes among persons testing hiv-positive. aim #3 will implement a poc nat-tailored behavioral intervention to evaluate impact on time to virologic suppression among plwh receiving art. aim #4 will quantify the acceptability and feasibility of implementation of poc nat in community and clinical settings and collect cost and related data for cost-effectiveness analyses. finally, in aim #5, a distinct but related study will compare the sensitivity, specificity, and agreement of multiple poc nats over a range of hiv rna levels.


Eligibility criteria:
inclusion criteria: * persons who are hiv-positive and seeking care at madison clinic. * 18 years of age or older * patient's provider is willing to deliver adherence intervention * patient is getting a laboratory rna viral load test that day. * able to read and speak english exclusion criteria: * patients of unknown hiv status * patients who have participated in the study before

Keywords: hiv point of care testing nucleic acid testing
copd in obese patients

Conditions: Copd; Obese; Obesity, Abdominal

Summary: the study included 176 patients with copd. the first group included 88 normal weight patients with copd: 71 men and 17 women, mean age 62.40 ± 8.83 years. the second group included 88 patients with copd and obesity: 64 men and 24 women, mean age 62.94 ± 5.96 years. we assessed the frequency of copd exacerbations in last 12 months, the severity of symptoms such as dyspnea, sputum production, fatigue. spirometry, six-minute walk test and analysis of body tissue type composition were performed. bode index was calculated. levels of leptin, adiponectin, interleukins-4,6,8,10, interferon-γ, c-reactive protein (crp), tumor necrosis factor receptor 1 (tnf-r1), tumor necrosis factor receptor 2 (tnf-r2), tumor necrosis factor alpha (tnf-α) were measured in blood serum.


Eligibility criteria:
inclusion criteria: * copd diagnosis, informed consent for voluntary participation in the study exclusion criteria: * patient participation in any interventional study, * copd exacerbation, * concomitant lung diseases, such as confirmed or suspected malignant lung disease or other respiratory disease, such as interstitial pulmonary fibrosis, tuberculosis, sarcoidosis, bronchial asthma, bronchiectasis, * concomitant diseases of other organs and systems, such as acute cardiovascular diseases, chronic kidney diseases and liver failure.

Keywords: spirometry inflammation copd
prediction of pain in total hip arthroplasty

Conditions: Pain, Postoperative

Summary: in this consecutive, prospective cohort study the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total hip arthroplasty.

the preoperative heat stimulation consists of short and long tonic heat stimulation. pain response is evaluated with an electronic visual analog scale. furthermore the investigators evaluate other factors possibly predictable for acute and subacute postoperative pain after total hip arthroplasty - demographic factors, preoperative pain related factors, psychosocial factors (hospital anxiety and depression scale and pain catastrophizing scale).

Eligibility criteria:
inclusion criteria: * ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total hip arthroplasty exclusion criteria: * bilateral/revision arthroplasty * disease affection central or peripheral nerve function * alcohol and medical abuse * daily use of opioids or glucocorticoids * malignancy * bmi \> 40 * depression * dementia or other cognitive dysfunction
virtual reality (vr) for prone pain procedures

Conditions: Virtual Reality; Anxiety; Pain

Summary: the purpose of this study is to evaluate the effectiveness of virtual reality (vr) distraction in patients undergoing interventional pain procedures in the prone position. vr has been shown to improve patient experience during interventional pain procedures, however, many of these procedures are done in the prone position making vr a challenge. this study will evaluate the effect of a vr headset and support in patients undergoing prone interventional pain procedures compared to control.


Eligibility criteria:
inclusion criteria: * patients aged 18 years old or older, who are referred to university of california davis pain medicine clinic and require an interventional pain procedure * english speaking and with the ability to understand oral and written instructions exclusion criteria: * pregnant women * prisoners * patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment
clinical evaluation of visco-assisted cypass® micro-stent implantation in patients with open angle glaucoma

Conditions: Open Angle Glaucoma

Summary: the purpose of this study is to assess the safety and effectiveness of the use of visco-assisted cypass® micro-stent implantation for the lowering of intraocular pressure (iop) in subjects who have open angle glaucoma (oag).

the study was conducted in 2 phases. only one eye per subject was treated for each independent phase. dose selection phase (cohort 1): subjects were randomized in a 1:1:1 ratio and implanted with either a cypass micro-stent with targeted delivery of 30 microliters (μl) ophthalmic 5 viscoelastic, a cypass micro-stent with targeted delivery of 60 μl of ophthalmic viscoelastic, or a cypass micro-stent without adjunct viscoelastic in the study eye. expansion phase (cohort 2): subjects were randomized in a 1:1 ratio and implanted with either the cypass micro-stent without adjunct viscoelastic or the cypass micro-stent with 60 μl of ophthalmic viscoelastic (based on dose selection results). subjects were randomized to treatment on the day of their surgical procedure. a total of 9 scheduled visits were planned including screening (day -45 to -2), baseline (day -15 to -1), surgery (day 0), 1 day (day 1), 1 week (day 5-9), 1 month (day 21-35), 3 month (day 70-98), 6 month (day 150-210), and 12 month (day 330-420) visits. the total expected duration of participation for each subject was up to 13 months.

Eligibility criteria:
inclusion criteria: * diagnosis of open angle glaucoma; * unmedicated iop between 21 - 36 mmhg, inclusive; * normal angle anatomy at site of intended cypass micro-stent implantation. exclusion criteria: * advanced glaucoma; * prior incisional glaucoma surgery; * acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma; * clinically significant ocular pathology other than glaucoma.
effects of exercise intervention and rehabilitation exercise intervention in patients with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Non-Insulin-Dependent

Summary: the purposes of the study are * to determine if a supervised exercise intervention is improving the metabolic parameters in type 2 diabetes patients * to investigate what kind of intervention (strength endurance training versus combined strength endurance training and rehabilitation exercise intervention)is more effective in improving the metabolic parameters in patients with type 2 diabetes * to assess which exercise intervention induces higher effects to the metabolic rate and cardiac and pulmonary capacity * to investigate what kind of intervention includes highest effects in long term persistence of these positive effects


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes (ada criteria) * admitted diabetes treatment will be diet and oral hypoglycemic agents exclusion criteria: * sports intervention \> 60 minutes per week medical conditions * proliferative retinopathy * instable coronary heart disease * acute clinically significant intercurrent disease * inability to perform scheduled physical activity programs

Keywords: diabetes exercise intervention rehabilitation metabolic rate sport